Visit 3: Operation

  1. StudyEvent: PREBOT Pilot
    1. Visit 1: Enrollment and Randomization
    2. Visit 2: Endoscopic intervention
    3. Visit 3: Operation
    4. Visit 4: POD 3
    5. Visit 5: Day of discharge
    6. Visit 6: POD 30
    7. Visit 7: 3 months post OP/ premature discontinuation
    8. Signature
  2. StudyEvent: Complications
    1. Complications
  3. StudyEvent: Readmission To Hospital (repeatable instrument)
    1. Readmission To Hospital (repeatable instrument)
  4. StudyEvent: Adverse Events (repeatable instrument)
    1. Adverse Events (repeatable instrument)
  5. StudyEvent: Concomitant Medication
    1. Concomitant Medication
  6. StudyEvent: Protocol Violation (repeatable instrument)
    1. Protocol Violation (repeatable instrument)
  7. StudyEvent: Patient report: EORTC QLQ-C30
  8. StudyEvent: Patient report: EORTC QLQ-PAN26
Laboratory Parameters (prior to surgery)
Beskrivning

Laboratory Parameters (prior to surgery)

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0543467
Date of blood test
Beskrivning

Date of blood test

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0849535
Measurement of Pancreatic amylase
Beskrivning

Measurement of Pancreatic amylase

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3274428
If yes: Pancreatic amylase
Beskrivning

Pancreatic amylase

Datatyp

float

Måttenheter
  • U/I
Alias
UMLS CUI [1,1]
C0301812
U/I
Measurement of lipase
Beskrivning

Measurement of lipase

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0373670
If yes: Lipase
Beskrivning

Lipase

Datatyp

integer

Måttenheter
  • U/l
Alias
UMLS CUI [1,1]
C0023764
U/l
Bilirubin
Beskrivning

Bilirubin

Datatyp

float

Måttenheter
  • mg/dl
Alias
UMLS CUI [1,1]
C0201913
mg/dl
Hemoglobin
Beskrivning

Hemoglobin

Datatyp

float

Måttenheter
  • g/dl
Alias
UMLS CUI [1,1]
C0019046
g/dl
Erythrocytes
Beskrivning

Erythrocytes

Datatyp

float

Måttenheter
  • /pl
Alias
UMLS CUI [1,1]
C0014792
/pl
Leucocytes
Beskrivning

Leucocytes

Datatyp

float

Måttenheter
  • /nl
Alias
UMLS CUI [1,1]
C0023516
/nl
Thrombocytes
Beskrivning

Thrombocytes

Datatyp

float

Måttenheter
  • /nl
Alias
UMLS CUI [1,1]
C0005821
/nl
INR
Beskrivning

INR

Datatyp

float

Alias
UMLS CUI [1,1]
C0525032
Creatinine clearance / GFR (estimated by Cockroft-Gault)
Beskrivning

GFR

Datatyp

float

Måttenheter
  • ml/min
Alias
UMLS CUI [1,1]
C2711451
UMLS CUI [1,2]
C0373595
ml/min
CRP
Beskrivning

CRP

Datatyp

float

Måttenheter
  • mg/l
Alias
UMLS CUI [1,1]
C0201657
mg/l
Complications (prior to surgery)
Beskrivning

Complications (prior to surgery)

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0543467
Postinterventional pancreatitis
Beskrivning

Postinterventional pancreatitis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030305
UMLS CUI [1,2]
C3272301
If yes, please fill out eForm 'Adverse Events'
Beskrivning

If yes, please fill out eForm 'Adverse Events'

Alias
UMLS CUI [1,1]
C3273494
UMLS CUI [1,2]
C0877248
Distal Pancreatectomy
Beskrivning

Distal Pancreatectomy

Alias
UMLS CUI [1,1]
C0176940
Distal Pancreatectomy performed
Beskrivning

Distal Pancreatectomy performed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0176940
UMLS CUI [1,2]
C0450010
If no, please specify reason
Beskrivning

specify reason

Datatyp

integer

Alias
UMLS CUI [1,1]
C1521902
If other, please specify reason
Beskrivning

Specify

Datatyp

text

Alias
UMLS CUI [1,1]
C1521902
If no distal pancreatectomy performed, please do data entry in eCRF as follows: 1. remaining documentation of Visit 3: Operation 2. skip Visit 4-6 and fill out 'premature trial termination' for reason DP not performed in Visit 7 3. documentation of AEs necessary for planned FU time of 3 months 4. eCRF signature
Beskrivning

If no distal pancreatectomy performed, please do data entry in eCRF as follows: 1. remaining documentation of Visit 3: Operation 2. skip Visit 4-6 and fill out 'premature trial termination' for reason DP not performed in Visit 7 3. documentation of AEs necessary for planned FU time of 3 months 4. eCRF signature

Alias
UMLS CUI [1,1]
C3273494
If no distal pancreatectomy performed, please do data entry in eCRF as follows: 1. remaining documentation of Visit 3: Operation 2. skip Visit 4-6 and fill out 'premature trial termination' for reason DP not performed in Visit 7 3. eCRF signature
Beskrivning

If no distal pancreatectomy performed, please do data entry in eCRF as follows: 1. remaining documentation of Visit 3: Operation 2. skip Visit 4-6 and fill out 'premature trial termination' for reason DP not performed in Visit 7 3. eCRF signature

Alias
UMLS CUI [1,1]
C3273494
Surgery details
Beskrivning

Surgery details

Alias
UMLS CUI [1,1]
C5204320
Date of distal pancreatectomy
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0176940
Beginning of skin incision
Beskrivning

Skin incision

Datatyp

time

Alias
UMLS CUI [1,1]
C2116297
End of skin closure
Beskrivning

Skin closure

Datatyp

time

Alias
UMLS CUI [1,1]
C1883250
UMLS CUI [1,2]
C0040223
Technique of surgery
Beskrivning

Technique

Datatyp

integer

Alias
UMLS CUI [1,1]
C0449851
If minimally invasive, please specify
Beskrivning

Specify

Datatyp

integer

Alias
UMLS CUI [1,1]
C1521902
Type of pancreatic transection
Beskrivning

Type of pancreatic transection

Datatyp

integer

Alias
UMLS CUI [1,1]
C0434050
UMLS CUI [1,2]
C0332307
If other, please specify
Beskrivning

Specify

Datatyp

text

Alias
UMLS CUI [1,1]
C1521902
Additional covering of the pancreatic remnant of any kind (e.g. ligamentum teres hepatis patch, mesh implantation or use of fibrin glue)
Beskrivning

covering of pancreatic remnant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4554476
UMLS CUI [1,2]
0030274
UMLS CUI [1,3]
C0439844
Location of the resection margin (in relation to the superior mesenterial/portal vein axis)
Beskrivning

Location of the resection margin

Datatyp

integer

Alias
UMLS CUI [1,1]
C0229985
UMLS CUI [1,2]
C0450429
UMLS CUI [1,3]
C0933844
UMLS CUI [1,4]
C0032718
UMLS CUI [1,5]
C0226742
Texture of pancreatic tissue
Beskrivning

Texture of pancreatic tissue

Datatyp

integer

Alias
UMLS CUI [1,1]
C1280424
UMLS CUI [1,2]
C0679033
Determination of pancreatic duct size
Beskrivning

Determination of pancreatic duct size

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030288
UMLS CUI [1,2]
C0456389
If yes: Pancreatic duct size
Beskrivning

Pancreatic duct size

Datatyp

integer

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C1521902
mm
Additional resections performed
Beskrivning

Additional resections performed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1706712
UMLS CUI [1,2]
C0728940
Intraoperative blood loss
Beskrivning

Intraoperative blood loss

Datatyp

float

Måttenheter
  • ml
Alias
UMLS CUI [1,1]
C5208110
ml
Red blood cell transfusion during surgery
Beskrivning

Perioperative RBC transfusion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0086252
UMLS CUI [1,2]
C1518988
If yes: Volume of red blood cell transfusion
Beskrivning

Volume RBC transfusion

Datatyp

float

Måttenheter
  • ml
Alias
UMLS CUI [1,1]
C0523098
ml
If yes, please specify
Beskrivning

If yes, please specify

Alias
UMLS CUI [1,1]
C1521902
splenectomy
Beskrivning

splenectomy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0037995
adrenalectomy
Beskrivning

adrenalectomy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001632
colectomy
Beskrivning

colectomy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009274
vascular resection
Beskrivning

vascular resection

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0728940
UMLS CUI [1,2]
C1801960
cholecystectomy
Beskrivning

cholecystectomy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0008320
other
Beskrivning

other

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205394
If other additional resection, please specify
Beskrivning

specify

Datatyp

text

Alias
UMLS CUI [1,1]
C1521902
If vascular resection, please specify
Beskrivning

If vascular resection, please specify

Alias
UMLS CUI [1,1]
C1521902
portal vein / superior mesenteric vein
Beskrivning

portal vein / superior mesenteric vein

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032718
UMLS CUI [1,2]
C0226742
inferior vena cava
Beskrivning

inferior vena cava

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042458
celiac trunc
Beskrivning

celiac trunc

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007569
hepatic artery
Beskrivning

hepatic artery

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019145
superior mesenteric artery
Beskrivning

superior mesenteric artery

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162861
Octreotide
Beskrivning

Octreotide

Alias
UMLS CUI [1,1]
C0028833
Perioperative application of octreotide (e.g. Sandostatin)
Beskrivning

Perioperative Octreotide

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1518988
UMLS CUI [1,2]
C3469597
Perioperativ Sepsis
Beskrivning

Perioperativ Sepsis

Alias
UMLS CUI [1,1]
C0243026
UMLS CUI [1,2]
C1518988
Occurence of perioperativ Sepsis
Beskrivning

Occurence

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2745955
If yes, please fill out eForm 'Adverse Events'
Beskrivning

If yes, please fill out eForm 'Adverse Events'

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3273494
Concomitant Medication
Beskrivning

Concomitant Medication

Alias
UMLS CUI [1,1]
C2347852
Any changes in Concomitant Medication since last visit
Beskrivning

Changes in Concomitant Medication since last visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3872643
UMLS CUI [1,2]
C0580105
If yes, please fill out eForm 'Concomitant Medication'
Beskrivning

If yes, please fill out eForm 'Concomitant Medication'

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1521902
Adverse Events
Beskrivning

Adverse Events

Alias
UMLS CUI [1,1]
C3872643
Any new Adverse Events occurred since last visit
Beskrivning

Adverse Events since last visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3872643
UMLS CUI [1,2]
C0205314
If yes, please fill out eForm 'Adverse Events'
Beskrivning

If yes, please fill out eForm 'Adverse Events'

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3273494
Protocol violations
Beskrivning

Protocol violations

Alias
UMLS CUI [1,1]
C1709750
Any protocol violations occurred since last visit
Beskrivning

Protocol violations occurred since last visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1291910
UMLS CUI [1,2]
C3872643
If yes, please fill out eForm 'Protocol Violations'
Beskrivning

If yes, please fill out eForm 'Protocol Violations'

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C3273494

Similar models

Visit 3: Operation

  1. StudyEvent: PREBOT Pilot
    1. Visit 1: Enrollment and Randomization
    2. Visit 2: Endoscopic intervention
    3. Visit 3: Operation
    4. Visit 4: POD 3
    5. Visit 5: Day of discharge
    6. Visit 6: POD 30
    7. Visit 7: 3 months post OP/ premature discontinuation
    8. Signature
  2. StudyEvent: Complications
    1. Complications
  3. StudyEvent: Readmission To Hospital (repeatable instrument)
    1. Readmission To Hospital (repeatable instrument)
  4. StudyEvent: Adverse Events (repeatable instrument)
    1. Adverse Events (repeatable instrument)
  5. StudyEvent: Concomitant Medication
    1. Concomitant Medication
  6. StudyEvent: Protocol Violation (repeatable instrument)
    1. Protocol Violation (repeatable instrument)
  7. StudyEvent: Patient report: EORTC QLQ-C30
  8. StudyEvent: Patient report: EORTC QLQ-PAN26
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Laboratory Parameters (prior to surgery)
C1254595 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Date of blood test
Item
Date of blood test
date
C0011008 (UMLS CUI [1,1])
C0849535 (UMLS CUI [1,2])
Measurement of Pancreatic amylase
Item
Measurement of Pancreatic amylase
boolean
C3274428 (UMLS CUI [1,1])
Pancreatic amylase
Item
If yes: Pancreatic amylase
float
C0301812 (UMLS CUI [1,1])
Measurement of lipase
Item
Measurement of lipase
boolean
C0373670 (UMLS CUI [1,1])
Lipase
Item
If yes: Lipase
integer
C0023764 (UMLS CUI [1,1])
Bilirubin
Item
Bilirubin
float
C0201913 (UMLS CUI [1,1])
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1,1])
Erythrocytes
Item
Erythrocytes
float
C0014792 (UMLS CUI [1,1])
Leucocytes
Item
Leucocytes
float
C0023516 (UMLS CUI [1,1])
Thrombocytes
Item
Thrombocytes
float
C0005821 (UMLS CUI [1,1])
INR
Item
INR
float
C0525032 (UMLS CUI [1,1])
GFR
Item
Creatinine clearance / GFR (estimated by Cockroft-Gault)
float
C2711451 (UMLS CUI [1,1])
C0373595 (UMLS CUI [1,2])
CRP
Item
CRP
float
C0201657 (UMLS CUI [1,1])
Item Group
Complications (prior to surgery)
C0009566 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Postinterventional pancreatitis
Item
Postinterventional pancreatitis
boolean
C0030305 (UMLS CUI [1,1])
C3272301 (UMLS CUI [1,2])
Item Group
If yes, please fill out eForm 'Adverse Events'
C3273494 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item Group
Distal Pancreatectomy
C0176940 (UMLS CUI [1,1])
Distal Pancreatectomy performed
Item
Distal Pancreatectomy performed
boolean
C0176940 (UMLS CUI [1,1])
C0450010 (UMLS CUI [1,2])
Item
If no, please specify reason
integer
C1521902 (UMLS CUI [1,1])
Code List
If no, please specify reason
CL Item
inoperability (1)
C0205187 (UMLS CUI [1,1])
CL Item
partial pancreatoduodenectomy performed (2)
C0728938 (UMLS CUI [1,1])
C0085162 (UMLS CUI [1,2])
CL Item
total pancreatectomy performed (3)
C0040511 (UMLS CUI [1,1])
CL Item
other (4)
C0205394 (UMLS CUI [1,1])
Specify
Item
If other, please specify reason
text
C1521902 (UMLS CUI [1,1])
Item Group
If no distal pancreatectomy performed, please do data entry in eCRF as follows: 1. remaining documentation of Visit 3: Operation 2. skip Visit 4-6 and fill out 'premature trial termination' for reason DP not performed in Visit 7 3. documentation of AEs necessary for planned FU time of 3 months 4. eCRF signature
C3273494 (UMLS CUI [1,1])
Item Group
If no distal pancreatectomy performed, please do data entry in eCRF as follows: 1. remaining documentation of Visit 3: Operation 2. skip Visit 4-6 and fill out 'premature trial termination' for reason DP not performed in Visit 7 3. eCRF signature
C3273494 (UMLS CUI [1,1])
Item Group
Surgery details
C5204320 (UMLS CUI [1,1])
Date
Item
Date of distal pancreatectomy
date
C0011008 (UMLS CUI [1,1])
C0176940 (UMLS CUI [1,2])
Skin incision
Item
Beginning of skin incision
time
C2116297 (UMLS CUI [1,1])
Skin closure
Item
End of skin closure
time
C1883250 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Technique of surgery
integer
C0449851 (UMLS CUI [1,1])
Code List
Technique of surgery
CL Item
minimally invasive (1)
C0282624 (UMLS CUI [1,1])
CL Item
open surgery (2)
C0348025 (UMLS CUI [1,1])
Item
If minimally invasive, please specify
integer
C1521902 (UMLS CUI [1,1])
Code List
If minimally invasive, please specify
CL Item
laparoscopic (1)
C0751429 (UMLS CUI [1,1])
CL Item
robotic (2)
C3850136 (UMLS CUI [1,1])
Item
Type of pancreatic transection
integer
C0434050 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Type of pancreatic transection
CL Item
scalpel with suture closure of the cut margin (1)
C0392220 (UMLS CUI [1,1])
C0009068 (UMLS CUI [1,2])
CL Item
linear stapler (2)
C1139962 (UMLS CUI [1,1])
CL Item
other (3)
C0205394 (UMLS CUI [1,1])
Specify
Item
If other, please specify
text
C1521902 (UMLS CUI [1,1])
covering of pancreatic remnant
Item
Additional covering of the pancreatic remnant of any kind (e.g. ligamentum teres hepatis patch, mesh implantation or use of fibrin glue)
boolean
C4554476 (UMLS CUI [1,1])
0030274 (UMLS CUI [1,2])
C0439844 (UMLS CUI [1,3])
Item
Location of the resection margin (in relation to the superior mesenterial/portal vein axis)
integer
C0229985 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C0933844 (UMLS CUI [1,3])
C0032718 (UMLS CUI [1,4])
C0226742 (UMLS CUI [1,5])
Code List
Location of the resection margin (in relation to the superior mesenterial/portal vein axis)
CL Item
left (1)
C0205091 (UMLS CUI [1,1])
CL Item
above (2)
C0456745 (UMLS CUI [1,1])
CL Item
right (3)
C0205090 (UMLS CUI [1,1])
Item
Texture of pancreatic tissue
integer
C1280424 (UMLS CUI [1,1])
C0679033 (UMLS CUI [1,2])
Code List
Texture of pancreatic tissue
CL Item
soft (1)
C0205358 (UMLS CUI [1,1])
CL Item
intermediate (2)
C0205103 (UMLS CUI [1,1])
CL Item
hard (3)
C0018599 (UMLS CUI [1,1])
Determination of pancreatic duct size
Item
Determination of pancreatic duct size
boolean
C0030288 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Pancreatic duct size
Item
If yes: Pancreatic duct size
integer
C1521902 (UMLS CUI [1,1])
Additional resections performed
Item
Additional resections performed
boolean
C1706712 (UMLS CUI [1,1])
C0728940 (UMLS CUI [1,2])
Intraoperative blood loss
Item
Intraoperative blood loss
float
C5208110 (UMLS CUI [1,1])
Perioperative RBC transfusion
Item
Red blood cell transfusion during surgery
boolean
C0086252 (UMLS CUI [1,1])
C1518988 (UMLS CUI [1,2])
Volume RBC transfusion
Item
If yes: Volume of red blood cell transfusion
float
C0523098 (UMLS CUI [1,1])
Item Group
If yes, please specify
C1521902 (UMLS CUI [1,1])
splenectomy
Item
splenectomy
boolean
C0037995 (UMLS CUI [1,1])
adrenalectomy
Item
adrenalectomy
boolean
C0001632 (UMLS CUI [1,1])
colectomy
Item
colectomy
boolean
C0009274 (UMLS CUI [1,1])
vascular resection
Item
vascular resection
boolean
C0728940 (UMLS CUI [1,1])
C1801960 (UMLS CUI [1,2])
cholecystectomy
Item
cholecystectomy
boolean
C0008320 (UMLS CUI [1,1])
other
Item
other
boolean
C0205394 (UMLS CUI [1,1])
specify
Item
If other additional resection, please specify
text
C1521902 (UMLS CUI [1,1])
Item Group
If vascular resection, please specify
C1521902 (UMLS CUI [1,1])
portal vein / superior mesenteric vein
Item
portal vein / superior mesenteric vein
boolean
C0032718 (UMLS CUI [1,1])
C0226742 (UMLS CUI [1,2])
inferior vena cava
Item
inferior vena cava
boolean
C0042458 (UMLS CUI [1,1])
celiac trunc
Item
celiac trunc
boolean
C0007569 (UMLS CUI [1,1])
hepatic artery
Item
hepatic artery
boolean
C0019145 (UMLS CUI [1,1])
superior mesenteric artery
Item
superior mesenteric artery
boolean
C0162861 (UMLS CUI [1,1])
Item Group
Octreotide
C0028833 (UMLS CUI [1,1])
Perioperative Octreotide
Item
Perioperative application of octreotide (e.g. Sandostatin)
boolean
C1518988 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
Item Group
Perioperativ Sepsis
C0243026 (UMLS CUI [1,1])
C1518988 (UMLS CUI [1,2])
Occurence
Item
Occurence of perioperativ Sepsis
boolean
C2745955 (UMLS CUI [1,1])
Item Group
If yes, please fill out eForm 'Adverse Events'
C0877248 (UMLS CUI [1,1])
C3273494 (UMLS CUI [1,2])
Item Group
Concomitant Medication
C2347852 (UMLS CUI [1,1])
Changes in Concomitant Medication since last visit
Item
Any changes in Concomitant Medication since last visit
boolean
C3872643 (UMLS CUI [1,1])
C0580105 (UMLS CUI [1,2])
Item Group
If yes, please fill out eForm 'Concomitant Medication'
C2347852 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
Adverse Events
C3872643 (UMLS CUI [1,1])
Adverse Events since last visit
Item
Any new Adverse Events occurred since last visit
boolean
C3872643 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
Item Group
If yes, please fill out eForm 'Adverse Events'
C0877248 (UMLS CUI [1,1])
C3273494 (UMLS CUI [1,2])
Item Group
Protocol violations
C1709750 (UMLS CUI [1,1])
Protocol violations occurred since last visit
Item
Any protocol violations occurred since last visit
boolean
C1291910 (UMLS CUI [1,1])
C3872643 (UMLS CUI [1,2])
Item Group
If yes, please fill out eForm 'Protocol Violations'
C1709750 (UMLS CUI [1,1])
C3273494 (UMLS CUI [1,2])